Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves foreign material entering the bloodstream, a significant injury risk.
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 10,516 units of X-Celerator Hydrophilic Exchange Guidewires. The recall involves specific catalog numbers and lot codes distributed worldwide, including the United States and numerous international markets.
The recall is due to a defect where the PTFE (polytetrafluoroethylene) coating material may delaminate and detach. This failure mode may lead to PTFE coating material entering the patient's bloodstream.
Healthcare providers and facilities should identify and stop using the affected guidewires. The source text does not specify a consumer action for the general public, as these are medical devices used in clinical settings.
The recalled product
- Product
- X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06…
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Affected units
- 10,516
Distribution
Part of a larger recall action
This product is one of 4 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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